Download Xpert® C. difficile

Xpert
C.difficile
®
Rapid and Accurate. It’s About Time.
Xpert C. difficile
®
Detection of Clostridium difficile in 45 minutes.
In Vitro Diagnostic Medical Device
A better way.
“Patients infected with C. difficile are a source
of transmission to other patients, therefore it is
important that infected patients are detected
as early as possible. Rapid molecular testing,
providing wholly accurate results in 45 minutes,
when combined with isolation of infected patients,
provides an important new weapon in our battle
against healthcare associated infections.”
Professor Richard James
Director of the Center for Healthcare Associated Infections
University of Nottingham
The Need
The Solution
C. difficile infections (CDI) have been increasing in incidence
and severity, and are associated with an increase in length
of hospital stays, costs, morbidity and mortality.1 CDI is also
reported to be the most common cause of hospital acquired
diarrhea and necessitates rapid and accurate diagnosis.
Xpert® C. difficile detects the presence of toxin-producing
Clostridium difficile in 45 minutes. Detection of three targets:
Toxin B, Binary Toxin (cdtA), and tcdC deletion provides
superior coverage and offers presumptive identification of the
027/NAP/BI epidemic strains. This new solution delivers both
speed and accuracy and eliminates the need for additional or
repeat testing.
• In major EU countries CDI incidence is reported at 11 per
10,000 admissions2
• Highly virulent (027-NAP1-BI) strains have caused
outbreaks of severe disease in Europe and North America —
with mortality rates above 50%3
Incremental costs associated with C. difficile infection2
Incremental
costs up to
€15,000
per infection
Contributing Cost Factors:
• incremental LOS
• isolation costs
• environmental cleanup
• additional therapies
LACK OF RELIABLE AND TIMELY DIAGNOSIS, TREATMENT, AND
INFECTION CONTROL CAN DRAMATICALLY INCREASE COSTS.
Currently screening tests lack sensitivity and it can take up to
72 hours before a result becomes available to the physicians.
This has forced clinicians to choose between speed or accuracy.
• Clinicians can promptly administer therapy for improved
patient outcomes
• Timely implementation of infection control initiatives to
reduce spread of infection within institution4
• Superior test sensitivity eliminates the need for additional or
repeat testing
CDI has become a substantive and growing burden in
hospitalized patients prompting the need for earlier
and accurate detection. The impact of Cepheid’s Xpert
C. difficile test can be significant: with 45-minute detection,
clinicians can now initiate therapy and appropriate infection
prevention and control measures sooner, leading to better
patient management.
Performance
Performance characteristics of Xpert® C. difficile were determined in a prospective investigation study by comparing Xpert C. difficile
on the GeneXpert® System with broth enriched toxigenic culture.
PERFORMANCE CHARACTERISTICS OF XPERT® C. DIFFICILE AS COMPARED TO TOXIGENIC CULTURE
Toxigenic Culture
Xpert C. difficile
C. difficile pos
negative
Toxin B+
316
117
negative
22
1841
sensitivity: 93.5%
specificity: 94.0%
Broad Coverage
The only rapid test which identifies three targets: Toxin B, Binary Toxin, and tcdC deletion.
XPERT C. DIFFICILE RESULT ALGORITHM
Individual Targets and Combination
Toxin B+
tcdC deletion
Binary Toxin
Internal Control
negative
–
–
–/+
+
C. difficile positive
+
–
–
N/A
C. difficile positive
+
–
+
N/A
C. difficile positive
+
+
–
N/A
Epidemic C. difficile positive
+
+
+
N/A
tcdA
tcdC
Xpert C. difficile
result
PATHOGENICITY LOCUS
tcdD
tcdE
tcdB
regulator
toxin b
cdtR
regulator
repressor deletion 117
cdtA
cdtB
binary toxin
targeted genes
Unique
Delivers immediate actionable results.
PRESUMPTIVE POSITIVE TOXIGENIC C. DIFFICILE 027/NAP1/BI
Rapid and Accurate.
Xpert C. difficile
®
• Fully automated process reduces handling time to just minutes
• Random access for flexibility and workflow optimization
• Rapid results to improve patient management
• Fully integrated reagent and instrument system for accuracy and reproducibility
WORKFLOW:
3 Easy Steps
Total hands-on time: 1 Minute
1
2
3
Insert swab into Elution
reagent vial and break at score
Vortex and dispense
Sample into Port S
Insert cartridge and
start assay.
ORDERING INFORMATION
Xpert® C. difficile (10 Cartridges with reagents) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Catalog No. GXCDIFFICILE-CE-10
References:
1. Zilberberg et al. Emerging Infectious Diseases, Vol 14, No 6, 2008
2. Kuijper et al. European Society of Clinical Microbiology & Infectious Diseases, CMI, 12 (Suppl 6), 2-18
3. Mundy et al. Infection 2007; 35: 300-307
4. National Prevalence Study of Clostridium Difficile in U.S. Healthcare Facilities. www. apic.org
The molecular revolution is here.
CORPORATE HEADQUARTERS
EUROPEAN HEADQUARTERS
904 Caribbean Drive
Sunnyvale, CA 94089 USA
Vira Solelh
81470 Maurens-Scopont, France
TOLL FREE
+1.888.336.2743
+1.408.541.4191
FAX +1.408.541.4192
PHONE
PHONE
FAX
EMAIL
www.Cepheidinternational.com
+33.563.82.53.00
+33.563.82.53.01
[email protected]
A better way.
THE PURCHASE OF THIS PRODUCT ALLOWS THE PURCHASER TO USE IT FOR THE PERFORMANCE OF DIAGNOSTIC SERVICES FOR HUMAN IN VITRO DIAGNOSTICS. NO GENERAL
PATENT OR OTHER LICENSE OF ANY KIND OTHER THAN THIS SPECIFIC RIGHT OF USE FROM PURCHASE IS GRANTED HEREBY. NO OTHER RIGHTS ARE CONVEYED EXPRESSLY, BY
IMPLICATION OR ESTOPPEL TO ANY OTHER PATENTS. FUTHERMORE, NO RIGHTS FOR RESALE ARE CONFERRED WITH THE PURCHASE OF THIS PRODUCT.
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